On September 29, 2022 Governor Gavin Newsome signed California Assembly Bill 1278 which passed the assembly in late August and the State Senate in 2021. AB 1278 would require physicians and surgeons (defined as a physician or surgeon licensed pursuant to the Medical Practice Act or an osteopathic physician or surgeon licensed by the Osteopathic Medical Board of California under the Osteopathic Act) to provide a written or electronic notice of the Open Payments database to a patient at the initial office visit.
The bill also requires physicians and surgeons to post an Open Payments database notice in each location where the licensee practices in an area that is likely to be seen by all individuals who enter the office. Additionally, as of January 1, 2024, all physicians and surgeons would need to conspicuously post the same Open Payments database notice on its website (if applicable).
If a physician or surgeon is employed by a health care employer, the health care employer is the one required to comply with the posting requirements, not the individual physician or surgeon. Additionally, these provisions do not apply to physicians and surgeons working in a hospital emergency room.
A violation of the bill’s provisions would constitute unprofessional conduct.
Specific Requirements
As noted above, physicians and surgeons will need to provide each patient a written or electronic notice of the Open Payments database at the initial office visit. The written notice shall also include a signature from the patient/patient representative and the date of the signature. Each patient or patient representative shall receive a signed and dated copy of the notice.
The written or electronic notice shall state: “The Open Payments database is a federal tool used to search payments made by drug and device companies to physicians and teaching hospitals. It can be found at https://openpaymentsdata.cms.gov.”
In addition to the website link to the Open Payments database, the notice must also include the following text, “For informational purposes only, a link to the federal Centers
for Medicare and Medicaid Services (CMS) Open Payments web page is provided here. The federal Physician Payments Sunshine Act requires that detailed information about payment and other payments of value worth over ten dollars ($10) from manufacturers
of drugs, medical devices, and biologics to physicians and teaching hospitals be made available to the public.”
Physicians and surgeons shall include a record of the notice in the electronic records for the patient. If a physician or surgeon does not maintain electronic records, the notice shall be included in the written records.
History
The bill was prompted by a constituent of Assembly member Nazarian. The patient underwent a procedure, unbeknownst to her, with an “off-label” device. The procedure and “off-label” device ultimately caused her significant complications, including nerve pain and deformity that required multiple operations. She later learned that the doctor who performed the initial surgery was driven by a financial relationship with the device manufacturer, having received more than $400,000 in the course of three years to research and promote it. The patient states that had she known about the relationship between the doctor and manufacturer, she may have made different choices.
Supporters of the bill understand that physician involvement in research and development with drug and device companies is not an automatic negative, and is actually necessary for medical advancement, but instead focus on the transparency and disclosure as a way to reinforce the trust between doctors and patients.
The legislation passed the Senate 21-4 and passed the Assembly 57-7. It was enrolled and presented to Governor Newsome for his signature on September 7, 2022.
Governor Newsome Signed
On September 29, 2022, Governor Newsome signed off on the legislation and it was Chaptered by the Secretary of State, in Chapter 750 of the 2022 Statutes.